Traditional antiserum treatments concentrate serum antibodies from other immune humans or animals. Antiserum derived from human, bovine and equine sources has been used or proposed. The antiserum may contain many constituents that are not desired: non-specific antibodies, infectious agents such as viruses, and immunoregulatory molecules that may cause adverse responses. Using antiserum to establish therapeutic levels of antibody in patient blood runs the risk of serum sickness complications due to potentially undesirable components of antiserum.
In contrast, defined synthetic antiserum includes only selected antibodies identified in blood products and produced under controlled conditions and formulation processing, eliminating undesired non-specific binding antibodies as well as other contaminations in the original serum. Traditional synthetic antibody therapies are designed based on a constructive design philosophy that includes one or very limited numbers of functionally therapeutic antibodies. The challenge in this design is that the effect of each candidate antibody are generally characterized independently, requiring considerable time and expense. This testing, performed in in vitro cultures does not always predict performance in an animal model due to interactions with other immune system responses such as antibody dependent cell-mediated cytotoxicity (ADCC), antibody dependent enhancement (ADE), and the innate immune system. Furthermore, testing in animal models does not necessarily predict performance in humans due to different physiologies between species. Thus, developing candidate mixtures of antibodies in a constructive design is time consuming and unpredictable. In addition, when the targeted agent is a virus capable of rapid evolution in response to selection pressures such as antibody binding and neutralization, a mixture of only a few antibodies poses the very real risk of not being effective against all viral variants, thereby enabling the emergence of viral strains that are immune to the antibody mixture.
Therefore there at least remains a need in the art for an efficient and cost-effective method for synthesizing an antiserum that provides protection and treatment for a biological agent and also replicates the natural immune response.